ORCHID-Miami: ORCHID: An Online Intervention for Persons With HIV (Miami)

Sponsor

University of Miami (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05935644

Collaborator

Northwestern University (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research is to test ORCHID (Optimizing Resilience & Coping with HIV through Internet Delivery), a skills-building intervention that improves mental health status for persons with HIV, who are at-risk for falling out of care.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS HPV Infection	Behavioral: ORCHID	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

ORCHID: A Novel Positive Affect Intervention for Aging, Racial/Ethnic Minoritized Women With HIV (Miami)

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ORCHID Group Participants in the ORCHID group will receive an online intervention that improves depressive symptoms and positive affect (emotions) for clinic-based persons living with HIV, for up to 6 months.	Behavioral: ORCHID The intervention includes 8 modules, which are delivered online, approximately 30 minutes per session, and participants will engage a minimum of once per week. Participants may also meet online or in-person with a navigator, up to 4 times.

Arm

Intervention/Treatment

Experimental: ORCHID Group

Participants in the ORCHID group will receive an online intervention that improves depressive symptoms and positive affect (emotions) for clinic-based persons living with HIV, for up to 6 months.

Behavioral: ORCHID

The intervention includes 8 modules, which are delivered online, approximately 30 minutes per session, and participants will engage a minimum of once per week. Participants may also meet online or in-person with a navigator, up to 4 times.

Outcome Measures

Primary Outcome Measures

Proportion of Participants who Complete ORCHID [Up to 6 months]
Average across all participants of the proportion of participants who login to all 8 ORCHID intervention sessions, calculated as total number of sessions opened (0-8) divided by 8.

Secondary Outcome Measures

Depression as measured by Patient Health Questionnaire (PHQ-9) [Up to 6 months]
Depression will be measured using the PHQ-9 (range 0 to 27), higher scores indicate higher levels of depressive symptoms
Positive Affect as measured by Positive and Negative Affect Schedule (PANAS) [Up to 6 months]
Positive affect will be measured using the PANAS, range is 10 to 50, higher scores indicate higher levels of positive emotions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Cis-gender women,
Receiving human immunodeficiency virus (HIV) care at the University of Miami Women's HIV Service,
Recent history (12-month) of cervical or anal dysplasia or human papilloma virus (HPV) positivity; AND a recent (12-month) history of one or more of the following:

drug use (alcohol, tobacco products, marijuana, illicit drugs) or ii) depression or iii) psychiatric condition (anxiety, post-traumatic stress disorder (PTSD)) or iv) unsuppressed HIV viral load d. All life stages - pregnant, non-pregnant, pre/post-menopausal

Exclusion Criteria:

Under 18
Not able to read/write English at the 6th grade level
Cognitively impaired adults (as documented in medical records)
Debilitating psychiatric condition (e.g. schizophrenia/bi-polar/psychotic disorders)
Prisoners

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami
Northwestern University

Investigators

Principal Investigator: Lunthita M Duthely, Ed.D., University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lunthita M. Duthely, Research Associate Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT05935644

Other Study ID Numbers:

20221247

First Posted:

Jul 7, 2023

Last Update Posted:

Jul 7, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lunthita M. Duthely, Research Associate Professor, University of Miami

depression

mobile applications

cortisol levels

Additional relevant MeSH terms:

Papillomavirus Infections

Study Results

No Results Posted as of Jul 7, 2023